Secondary Databased Post-marketing Surveillance Study of BNT162b2
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 14,302,529
- 试验地点
- 1
- 主要终点
- Frequency of Adverse Events of Special Interest (AESI) - Measure of Occurrence
研究概览
简要总结
This study is to assess the post-marketing safety of BNT162b2 products using nationwide population-based database in Republic of Korea.
详细描述
This study is a retrospective, non-interventional, observational study using Korean Disease Control and Prevention Agency-COVID-19-National Health Insurance Service (K-COV-N) database that includes COVID-19 vaccination/infection and claims data in Korean population. For the primary objective, cohort and self-controlled design will be used for measure of occurrence and measure of association, respectively. For the secondary objective, cohort design will be used for measure of occurrence.
Primary objective:
- To describe the frequency and estimate the incidence ratio of adverse events of special interest (AESIs) following exposure to Comirnaty Injection among individuals aged 6 months or older in the Republic of Korea
- To evaluate the relative risk of AESIs following exposure to Comirnaty Injection among individuals aged 6 months or older in the Republic of Korea, using a self-controlled case series (SCCS) design
Secondary objective:
- To describe the frequency and estimate the incidence ratio of severe COVID-19 outcomes (COVID-19 hospital admission, COVID-19 intensive care unit [ICU] admission, and COVID-19 death).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 6 Months 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Primary Objectives 1-
- •Measure of Occurrence Inclusion Criteria For the measure of occurrence, analytical populations will include following individuals,
- •Who meet the predefined criteria for each study population.
- •With enrollment in the national insurance during the observation period, as well as during the clean window prior to the start of the observation period.
排除标准
- •For the measure of occurrence, analytical populations will exclude following individuals,
- •With diagnosis of AESI during the AESI-specific clean window; or
- •With diagnosis of AESI between first dose and second/third dose of primary series when analyzing for the second/third dose.
- •Measure of Association Inclusion Criteria For the measure of association, analytical populations will include following individuals,
- •Who meet the predefined criteria for each study population.
- •With enrollment in the national insurance during the observation period, as well as during the clean window prior to the start of the observation period; and
- •Who had incident AESI during the observation period. Exclusion Criteria For the measure of association, analytical populations will exclude following individuals,
- •Who do not have both risk and control window time. If an individual disenrolls, dies, or reaches the end of the study period during the risk window prior to accumulating any control window time, he/she will be excluded; or
- •With a diagnosis of AESI during the AESI-specific clean window.
- •Secondary Objective Inclusion Criteria For the secondary objective, the study populations will include following individuals,
- •Who meet the predefined criteria for each study population. Exclusion Criteria
研究组 & 干预措施
All booster recipients using bivalent vaccine
All individuals who received booster recipients using bivalent vaccine (12 years of age or older).
干预措施: Tozinameran (BNT162b2) / Riltozinameran (BNT162b2 OMI BA.1) (Biological)
All booster recipients using bivalent vaccine
All individuals who received booster recipients using bivalent vaccine (12 years of age or older).
干预措施: Tozinameran (BNT162b2) / Famtozinameran (BNT162b2 OMI BA.4-5) (Biological)
Single-dose primary series recipients with bivalent vaccine
All individuals who received single-dose primary series recipients with bivalent vaccine (12 years of age or older).
干预措施: Tozinameran (BNT162b2) / Riltozinameran (BNT162b2 OMI BA.1) (Biological)
Single-dose primary series recipients with bivalent vaccine
All individuals who received single-dose primary series recipients with bivalent vaccine (12 years of age or older).
干预措施: Tozinameran (BNT162b2) / Famtozinameran (BNT162b2 OMI BA.4-5) (Biological)
Primary series recipients with first dose of monovalent vaccine and second dose of bivalent vaccine
All individuals who received primary series recipients with first dose of monovalent vaccine and second dose of bivalent vaccine (12 years of age or older).
干预措施: Tozinameran (BNT162b2) / Riltozinameran (BNT162b2 OMI BA.1) (Biological)
Primary series recipients with first dose of monovalent vaccine and second dose of bivalent vaccine
All individuals who received primary series recipients with first dose of monovalent vaccine and second dose of bivalent vaccine (12 years of age or older).
干预措施: Tozinameran (BNT162b2) / Famtozinameran (BNT162b2 OMI BA.4-5) (Biological)
Second booster recipients with monovalent vaccine
All individuals who received second booster recipients with monovalent vaccine (5 years of age or older).
干预措施: Tozinameran (BNT162b2) (Biological)
First booster recipients with monovalent vaccine
All individuals who received first booster recipients with monovalent vaccine (5 years of age or older).
干预措施: Tozinameran (BNT162b2) (Biological)
All primary series recipients using monovalent vaccine
All individuals who received first dose with monovalent vaccine as primary series (6 months or older).
干预措施: Tozinameran (BNT162b2) (Biological)
结局指标
主要结局
Frequency of Adverse Events of Special Interest (AESI) - Measure of Occurrence
时间窗: Up to 270 days after vaccination
Measure of Occurrence (Cohort design) The frequency of AESIs will be analyzed.
Incidence of Adverse Events of Special Interest (AESI) - Measure of Occurrence
时间窗: Up to 270 days after vaccination
Measure of Occurrence (Cohort design) The incidence of AESIs will be analyzed.
Incidence of Adverse Events of Special Interest (AESI) - Measure of Association
时间窗: Up to 270 days after vaccination
Measure of Association (Self-Controlled Design) The incidence of AESIs will be analyzed.
次要结局
- Frequency of Severe COVID-19 Outcomes(Up to 150 days after vaccination)
- Incidence of Severe COVID-19 Outcomes(Up to 150 days after vaccination)